About the service
We support our clients in all matters relating to medicinal products, medical devices, dietary supplements and special dietary uses.
F/K PHARMA: Comprehensive legal services in the pharmaceutical industry.
Types of pharmaceutical law services:
- contract manufacturing;
- laboratory testing;
- quality contracts;
- distribution contracts;
- marketing contracts;
- logistics contracts;
- Chief Pharmaceutical Inspectorate inspection proceedings;
- export of medicinal products
- compliance – audits;
- creation of internal procedures;
- manufacturing and marketing authorizations business licenses (wholesalers, pharmacies) creation of marketing structures;
- advertising;
- trademark registration;
- transfer of rights to pharmaceutical products
Pharmacy Law
Our clients can count on the expert assistance of Fortak & Karasiński Radcowie Prawni Sp. P. law firm in all matters related to the operation of pharmacies. We provide ongoing advice, meeting the needs of both pharmacy chains and individual pharmacists.
F/K PHARMA: Your partner for legal services in the pharmaceutical industry
F/K PHARMA – a reliable partner for legal services in the pharmaceutical industry. We offer comprehensive legal support to both Polish and international companies operating in the pharmaceutical sector. Our knowledge and experience extends to manufacturers and distributors of medicinal products, as well as pharmacies with a diverse range of activities.
Diverse legal services in the pharmaceutical industry
At F/K PHARMA, we offer a wide range of legal services tailored to the needs of the pharmaceutical industry, including:
- Contract manufacturing: We help you understand the intricacies of manufacturing contracts, ensuring compliance and quality control;
- Laboratory testing: Our services include drafting contracts for laboratory testing, ensuring product safety and efficacy;
- Quality contracts: We help establish rigorous quality agreements that meet industry standards;
- Distribution agreements: Our legal expertise includes distribution agreements, facilitating the smooth flow of pharmaceutical products;
- Marketing agreements: We offer support in creating marketing agreements that effectively promote your pharmaceutical products;
- Logistics agreements: We ensure the efficient movement of pharmaceutical products through logistics agreements;
- GIF (General Pharmaceutical Inspectorate) Inspection proceedures: We provide support during regulatory inspections and investigations by the GIF;
- Export of Medicinal Products: We assist with all legal issues related to the export of medicinal products, ensuring compliance with international regulations;
- Compliance and Audits: We conduct compliance audits and develop internal procedures, ensuring compliance with industry regulations;
- Permits and Licenses: Our services include obtaining manufacturing and marketing permits, as well as licenses for various pharmaceutical activities, including pharmaceutical wholesalers and pharmacies;
- Shaping Distribution Structures: We help design efficient distribution structures that optimize the flow of pharmaceutical products;
- Advertising Compliance: We ensure that your advertising activities related to pharmaceutical products comply with regulatory requirements;
- Trademark Registration: We handle trademark registration, protecting your brand identity;
- Transfer of Pharmaceutical Rights: We assist in the transfer of rights related to pharmaceutical products.
Our professionalism is a support for your success.
At F/K PHARMA, we understand the unique challenges and regulatory specifics of the pharmaceutical industry.
Our dedicated team of legal experts is committed to providing solutions that not only meet regulatory requirements, but also contribute to the success and growth of your pharmaceutical business.
Pharmaceutical law – complete service in its scope
Pharmaceutical law is one of the most complex and dynamically changing branches of law, with a direct impact on the activities of companies in the pharmaceutical and medical industries. It includes regulations governing the production, distribution, marketing and advertising of medicinal products and medical devices. The firm specialises in providing comprehensive services to companies in the pharmaceutical sector, offering legal advice on all aspects of pharmaceutical law. With these services, clients can count on precise and up-to-date legal solutions to support their daily business operations.
Cooperation with our law firm is a guarantee of understanding the regulations governing the introduction of new drugs to the market, issues related to product registration, as well as requirements for compliance with EU standards. We make sure that pharmaceutical companies can focus on developing their business, leaving legal and formal issues to us. With this support, companies can avoid legal risks and focus on bringing innovative solutions to the medical market.
Support for the pharmaceutical industry
The law firm offers full legal support to entities operating in the pharmaceutical industry, whether large corporations or smaller companies developing innovative products in the pharmaceutical market. We provide not only ongoing legal services, but also advice on legal strategy tailored to the specifics of the pharmaceutical market. We understand the importance of responding quickly to regulatory changes, so our services include monitoring legislative changes and their impact on our clients’ business.
The goal is not only to ensure legal compliance, but also to optimise legal processes that can contribute to business success. We provide advice on licensing agreements, patent protection and trademark protection. We also support companies in litigation and administrative proceedings that arise from violations of pharmaceutical law. All services are perfectly tailored to the needs of the industry, and thanks to our extensive experience, legal security is ensured in every aspect of the business.
An experienced lawyer – why is it so important?
Knowledge of pharmaceutical law is crucial to ensure the smooth operation of businesses in this industry. The firm has a team of experienced lawyers who have in-depth knowledge and extensive experience in pharmaceutical law. Choosing the right lawyer in this area can determine a company’s success – from launching new products to the market to meeting stringent regulatory requirements.
Our lawyers provide advice at every stage of a pharmaceutical company’s operations – from clinical trials, product registration and approval, to legal support for the launch of medicines on the market. With assistance, clients can count on support in interpreting complex regulations, which often change with new EU and national regulations. A well-chosen pharmaceutical law lawyer is not only a guarantee of legal security, but also an opportunity to avoid costly mistakes and penalties.
Better understanding of regulations and entitlements
Pharmaceutical law covers a wide range of regulations that govern both the activities of pharmaceutical companies and the process of marketing products. A law firm with an emphasis on pharmaceutical law is a team of experts who understand the intricacies of these regulations and are able to provide clear, understandable guidelines that facilitate the day-to-day operations of our clients. With us, any pharmaceutical company can be confident that it is operating in compliance with current regulations, minimising legal and financial risks.
As part of our services, we provide a full legal analysis of our clients’ operational processes, ensuring that they comply with legal requirements at every stage of their operations. Our experience enables us to respond effectively to changes in the law and to assist in adapting operations to new regulations. We take a personalised approach to our clients, tailoring legal solutions to the specific needs of each company operating in the pharmaceutical market.
Pharmaceutical Law – A law firm that makes operations easy and legal
For companies operating in the pharmaceutical market, it is crucial not only to comply with regulations, but also to optimise operations from a legal perspective. The law firm ensures that all activities comply with the law, while simplifying them enough so that they do not impose an undue burden on clients. This allows companies to focus on their core business, knowing that legal issues are under control.
The services offered range from strategic advice to support in day-to-day legal matters, such as drafting and reviewing contracts, representing clients before administrative authorities and supporting them in litigation. With extensive experience and knowledge, all clients can be confident that their business is being conducted in a manner that complies with applicable laws, and that all business decisions are made with a full understanding of their legal consequences.
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